course instructor
David E. Wiggins
Analytical/Stability Consultant
David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.
Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions, ANDA submissions and FDA general and PAI inspections.
Mr. Wiggins has over 35 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.
Danielle DeLucy, MS
Owner, ASA Training & Quality Consulting LLC
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 23 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
Charlie Neal
Owner and Senior Consultant for Premier Quality Consulting
Charlie Neal, Jr., Owner and Senior Consultant for Premier Quality Consulting, has been in the Pharmaceutical industry for over thirty-five years. He has a wealth of hands-on technical experience acquired from the chemical, drug, device, and pharmaceutical industries. His experience crosses into many areas of these industries including Research, Development, Process Engineering, Validation, Technical Transfers, Manufacturing, Quality, Compliance, Project Management and Sales and Marketing.
Mr. Neal has written and presented numerous papers on Qualification and Validation and their requirements in the Life Science industry. His expertise was further expanded while an active member of the Institute of Validation Technology's Editorial Board. Mr. Neal has written and published articles on Technology Transfers and has presented on these topics internationally, including in Tokyo, Japan. He has authored a chapter on Transdermal Process Validation that was published in the 3rd edition of Pharmaceutical Process Validation.
His company, Premier Quality Consulting was established to offer consulting expertise to the Pharmaceutical and Bio-Tech companies.